What happened
Shares of Apellis Pharmaceuticals (APLS 4.03%) were down more than 9% on Wednesday, after falling as much as 12% earlier in the day. The company's shares fell following a short-seller report on the pharmaceutical company. The stock is down more than 24% so far this year.
So what
Favus Institutional Research called into question data regarding Apellis' lead therapy, Syfovre, which is the only therapy approved by the Food and Drug Administration (FDA) to treat geographic atrophy secondary to age-related macular degeneration. The report stated that the trials didn't sufficiently report 14 cases of retinal vasculitis, an inflammatory condition that kills blood vessels, in patients receiving the therapy.
The news comes just a couple of days after Apellis said that the therapy had been given a permanent J-code, effective Oct. 1, by the Centers for Medicare & Medicare Services (CMS), allowing Syfovre to be covered for Medicare Part B plans.
On Aug. 29, Apellis said it was doing restructuring that would save $300 million through 2024 and boost sales for Syfovre and Empaveli, its two marketed products. Syfovre was just approved by the FDA in February, and through the first six months, the company said the drug brought in $85.7 million in sales. Empaveli, first approved in 2021 to treat nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease, brought in $42.7 million in the first six months.
Now what
Apellis will likely bounce back from the short-seller report. In the second quarter, the company reported it had $616.3 million in cash, enough to fund operations into 2025. It also said it had $89.6 million in revenue in the quarter, up 473% year over year. Its quarterly earnings per share (EPS) loss was $1.02, compared to an EPS loss of $1.46 in the same period last year.
